GDUFA Research Outcomes

OA Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.

• All(163)
• Posters(20)
• Presentations(124)
• Papers(19)

• A Population PK Based Model-Integrated BE Platform

  Chen, X; Nyberg, H; Assawasuwannakit, P; Ryeznik, Y; Karlsson, M

• Current Scientific Considerations in Modeling for In Vitro BE of Topically Administered Ophthalmics

  Chandran, Sajeev

• Approaches in Establishing BE Safe Space for Oral Solid Dosage Form

  Chakraborty, Sumon

• Use of Mechanistic Modelling to Determine the Sensitivity of in vitro CQAs to Regional Lung Deposition and Predict PK for OIDPs

  Butler, Clare

• Impact of Excipients on Drug Permeation to Support Biowaivers for Non-Q1/Q2 Products

  Bode, Chris

• Scientific Challenges Related to Establishing Q1/Q2 Sameness-An Industry Perspective

  Zhao, Liang

• IVPT Studies with Sunscreen Products: Potential Regulatory Utility

  Hakeem, Susan

• Relevant Challenges with IVRT with Iron-Carbohydrate Complexes: Application to IVIVC Models

  Hartka, Kathryn

• Regulatory Perspective: Challenges and Opportunities to Enhance Model Sharing upon Regulatory Use

  Babiskin, Andrew

• Novel Model-Integrated Designs for Bioequivalence Studies of LAI Products: A Complete Framework with the MonolixSuite

  Ayral, Geraldine